UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036321
Receipt number R000040733
Scientific Title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Date of disclosure of the study information 2019/06/01
Last modified on 2021/03/02 18:05:15

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Basic information

Public title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons

Acronym

The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons

Scientific Title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons

Scientific Title:Acronym

The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of NMN oral administration on the body composition in elderly persons

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the skeletal muscle index by the bioelectrical impedance analysis

Key secondary outcomes

1) To evaluate the parameters related to glucose metabolism
2)To evaluate the vascular endothelial function by FMD


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects receive 250 mg/day of NMN for 12 weeks.

Interventions/Control_2

Subjects receive placebo for 12 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1)the healthy subjects who agree to the study.
2)Body Mass Index 22-28
3)no smoking history

Key exclusion criteria

1)The subjects who take functional food that may affect the trial
2)The subjects who take more than one hour daily exercise for more than 6 months
3)The subjects with the history of serious disease (malignant neoplasms, cardiac failure and myocardial infarction )
4)The subjects with chronic disease
5)The subjects who take medicines
6)The subjects with allergic disorders.
7)The subjects who participate in any clinical trial within 90 days of the commencement of the trial
8)The subjects judged as ineligible by clinical investigators

Target sample size

42


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Igarashi

Organization

The Unversity of Tokyo Hospital

Division name

Department of Diabetes and Metabolic Diseases

Zip code

113-8655

Address

7-3-1 Hongo Bunkyo-ku

TEL

03-3815-5411

Email

igarashi-tky@umin.ac.jp


Public contact

Name of contact person

1st name Masaki
Middle name
Last name Igarashi

Organization

The University of Tokyo Hospital

Division name

Department of Diabetes and Metabolic Diseases

Zip code

113-8655

Address

7-3-1 Hongo Bunkyo-ku

TEL

03-3815-5411

Homepage URL


Email

igarashi-tky@umin.ac.jp


Sponsor or person

Institute

Department of Diabetes and Metabolic Diseases, The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Corporation Life Sciences Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo, Clinical Research Review Board

Address

7-3-1 Hongo Bunkyo-ku

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 02 Month 07 Day

Date of IRB

2019 Year 03 Month 29 Day

Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 27 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name